Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324974
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2006-05-09
Brief Title:
The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Randomized Multi-Center Double-Blind Placebo-Controlled Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension once daily QD in infants with gastroesophageal reflux symptoms during a 4-week treatment period
Detailed Description:
This study will be conducted by approximately 20 investigative sites in the US and Poland Participants who qualify will be randomized in equal proportions to receive either lansoprazole Pediatric Suspension 02-03 mgkgday in infants 10 weeks of age or 10-15 mgkgday in infants 10 weeks of age or Placebo This study consists of three periods Pretreatment Period of 7-14 days Double-Blind Treatment Period of 4 weeks Dosing and the Post-Treatment Period of 30 days Follow-Up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-2358 | REGISTRY | WHO | None |
| 2006-000957-23 | EUDRACT_NUMBER | None | None |